James Browne (Wexford, Fianna Fail)
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174. To ask the Minister for Health the position regarding the provision of access to Spinraza in view of a fresh price offer by the drug company in July 2018; and if he will make a statement on the matter. [42669/18]

Eamon Scanlon (Sligo-Leitrim, Fianna Fail)
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177. To ask the Minister for Health when the drug Spinraza will be approved for spinal muscular atrophy sufferers; and if he will make a statement on the matter. [42676/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 174 and 177 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health does not have any statutory power or function in relation to reimbursement of medicines.

For a medicine to be considered for reimbursement by the HSE, it must first have a marketing authorisation from the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA), before being assessed under the 2013 Act.

Nusinersen (Spinraza) is indicated for the treatment of 5q spinal muscular atrophy (SMA), a disorder characterised by progressive muscle atrophy and weakness.

In May 2017, the EMA granted market authorisation for nusinersen and in October 2017, the HSE received a reimbursement application for nusinersen.

In December 2017, the NCPE completed a HTA of nusinersen and did not recommend reimbursement at the price submitted. The application is being considered by the Rare Diseases Medicinal Products/Technology Review Committee and the HSE Drugs Group and is due to be considered by the HSE Leadership Team shortly, following which the final decision will be notified.

James Browne (Wexford, Fianna Fail)
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175. To ask the Minister for Health his views on a recent statement (details supplied) regarding the proven success and efficacy of Translarna as a drug to treat Duchenne muscular dystrophy; and if he will make a statement on the matter. [42670/18]

Simon Harris (Wicklow, Fine Gael)
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The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act does not give the Minister for Health any powers in this regard.

The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

The HSE has received a new application for the reimbursement of Ataluren (Translarna) from PTC Therapeutics.

The application is being assessed at present in accordance with the criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013 and is due to be discussed by the HSE Drugs Group shortly.